Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories— 510(k) K252871
Substantially EquivalentStryker Leibinger GmbH & Co KG
FDA 510(k) clearance K252871 for Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories, Substantially Equivalent on 2026-02-06. Applicant: Stryker Leibinger GmbH & Co KG. Device class: 2.
Summary
Stryker Leibinger lists four items: Spine Guidance 5.3 Software, Q Interbody Instruments, Elite Q Attachments, and Elite Cutting Accessories. They're filed under product code OLO, orthopedic stereotaxic instrument, and the record doesn't describe them beyond those names.
Class II, 21 CFR 882.4560. The Orthopedic review panel handled it as a Traditional 510(k), though the record lists Neurology as the classification panel.
Stryker Leibinger filed from Freiburg Im Breisgau, Germany. FDA found it substantially equivalent 149 calendar days after receipt (September 10, 2025 to February 6, 2026).
Clearance details
- Applicant
- Stryker Leibinger GmbH & Co KG
- Product code
- Product code OLO
- Device class
- Class 2
- Regulation
- 21 CFR 882.4560
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Freiburg Im Breisgau, DE
Recent devices under product code OLO
view allMore clearances from Stryker Leibinger GmbH & Co KG
view allAdverse events under product code OLO
product code OLO- Death
- 11
- Injury
- 2,799
- Malfunction
- 11,105
- Other
- 1
- Total
- 13,916
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.